Efforts to track prescription drug distribution, thus far, have been left up to states, and have produced marginal results, at best. A draft bill unveiled this week by four U.S. senators, however, aims to change all of that.
The bill--written by Sens. Michael Bennet (D-Colo.), Richard Burr (R-N.C.), Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.)--calls for the creation of a national electronic tracking system over a 10-year span that would serve as a replacement for the "patchwork of state product tracing laws," according to an announcement. It would shift tracing efforts from "lot-level" to "unit-level."
It requires that the entire drug supply chain, from manufacturers to dispensers, electronically provide transaction information during changes in ownership, and also calls on the U.S. Food and Drug Administration to keep a database of wholesale drug distributors, for whom licensure requirements would be strengthened. The database would be hosted on the FDA's website and accessible to the public.
Bennet cited a "record number of recalls" in championing the bill. Currently, he said, "we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills," which he added "could mean the difference between life and death."
Harkin, meanwhile, said the bill helps to ensure both the integrity and security of the prescription drug distribution system. "To ensure consumers know that the medications they take are safe--not adulterated, counterfeit, or otherwise compromised, it is important to know where these drugs have been at every step of the way--from the manufacturer to the pharmacy," he said.
The Institute of Medicine, in a report published in February, calls for data tracking and technology to combat counterfeit drugs. It recommends that FDA establish a public database similar to what is proposed in the draft bill, although the agency has been working since at least last spring on such efforts.
To learn more:
- here's the draft bill (.pdf)
- here's the accompanying announcement